The US Food and Drug Administration has approved Dupixent (dupilumab) for pediatric patients aged 2 to 11 years with chronic spontaneous urticaria who remain symptomatic despite histamine-1 antihistamine therapy, extending its prior indication in adolescents and adults. Chronic spontaneous urticaria is a type 2 inflammatory skin disease characterized by recurrent hives and pruritus that can impair quality of life, particularly in pediatric patients with limited treatment options.

The approval was supported primarily by findings from the Phase 3 LIBERTY-CUPID clinical program in patients with chronic spontaneous urticaria (CSU). This included two randomized, placebo-controlled Phase 3 trials in patients aged 6 years and older, along with pharmacokinetic and safety data from a single-arm Phase 3 study in children aged 2 to 11 years. In the randomized trials, dupilumab added to standard-of-care antihistamines reduced itch severity and overall urticaria activity compared with antihistamines alone at 24 weeks. Treatment was also associated with higher proportions of patients achieving well-controlled disease or complete response. A third randomized trial provided additional safety data and evaluated dupilumab in patients aged 12 years and older who had an inadequate response or intolerance to anti–immunoglobulin E therapy.

Safety outcomes across studies were consistent with the established safety profile of dupilumab in dermatologic indications. Injection site reactions were the most frequently reported adverse events and occurred more often in patients receiving dupilumab compared with placebo. No new safety concerns were identified in pediatric patients aged 2 to 11 years with CSU.

Dupilumab is a fully human monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling pathways, which contribute to type 2 inflammation. The therapy is administered via subcutaneous injection with dosing based on patient age and weight, and may be administered in clinical settings or at home following caregiver training.

This authorization establishes dupilumab as the first biologic therapy approved in the US for young children with uncontrolled CSU. It expands its use in pediatric patients as across five diseases driven in part by type 2 inflammation for which dupilumab is now approved in children younger than 12 years of age.

Source: Sanofi